Introduction: -

Pharmaceutical Development Services (PDS) provides a consultancy service for pharmaceutical and biopharmaceutical products advising on drug development and production strategy including paediatric product development. This includes the development, supply and regulatory control of new and existing pharmaceutical products. PDS was formed in 2000 and now boasts a staff of 10. PDS also works with a network of consultants who can provide specialist technical knowledge when required for a particular project. PDS can supply experienced interim managers for senior positions in Regulatory Affairs, Pharmaceutical Development and Quality Assurance.

Website address www.pharmdservices.com.

Clients: -

The clients of PDS vary from small start- up biotechnology companies to large multi-national pharmaceutical companies. An increasing number of clients are located overseas.

Contractor Management: -

PDS assists companies in the placing of work with CRO's from the preclinical stage to Phase 3. This involves CRO selection for particular projects depending on their skills.  PDS also advises on CRO issues and how to avoid the pitfalls on contracting out technical work.

Technology Transfer: -

PDS audits laboratories and manufacturing facilities, including contractors for clients. Audits can be performed according to GMP, GDP and GCP guidelines. PDS can advise on quality assurance strategy, and also provide preparation for pre-approval and other regulatory inspections. PDS offers a contract QP service, with staff who are eligible for nomination as QPs under the permanent provisions of 2001/83/EC and 2001/20/EC, and who are able to QP release both commercial and investigational medicinal products.

Technical Development: -

PDS advises companies on the strategy for introducing a new product, from pre-clinical technical development to a multi-national commercial launch. This involves project management, due diligence, production strategy, launch strategy, technology transfer and regulatory issues. This ensures that a new product is launched which meets all of the requirements and is marketed properly with the right amount of product in the right place at the right time.

Regulatory Affairs: -

PDS provides strategic regulatory advice and support for agency submissions, due diligence and writing regulatory dossiers through to dealing with responses from regulatory authorities after submission of the dossier. As well as small molecules and botechnology compounds, PDS also has expertise with herbal medicines, nutraceuticals, cosmetics and medical devices.

Expert Witness: -

We also offer an Expert Witness service, for advice and guidance on the resolution of legal disputes. These can range from formulation, safety, control and regulatory issues pertaining to patents.

Training:-

We provide expert in-house and public training courses through our sister business PharmaTraining Services (www.pharmatrainingservices.com). See the website for our current training services or call Michael Gamlen to discuss your in-house training requirements.

PDS always welcomes informal enquiries, and will be happy to speak to you.

We look forward to hearing from partners interested in developing, registering and supplying small volume products including paediatric dosage forms.  We offer an all-inclusive, full product development, registration and supply service.